MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 HOOD; GOWN, SURGICAL

Catalog Number	0400800000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 2 devices investigation type have not yet been determined.Additional information: 2 devices were labeled for single-use.2 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had debris in sterile package.2 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 2 previously reported events are included in this follow-up record.  product return status 2 devices were received.  event confirmation status 2 reported events were confirmed; the cause traced to manufacturing.Evaluation results 2 devices were found to be affected by foreign material in sterile packaging.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had debris in sterile package.2 events had no patient involvement; no patient impact.

• Brand Name: T4 HOOD
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8284711
• Report Number: 0001811755-2019-00242
• Device Sequence Number: 1306649
• Product Code: FYA
• UDI-Device Identifier: 04546540152626
• UDI-Public: 4546540152626
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 0400800000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 12/25/2018
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1